Therapeutic and diagnostic methods using soluble t cell...

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G01N 33/53 (2006.01) C07K 16/28 (2006.01) G01N 33/564 (2006.01) G01N 33/569 (2006.01) G01N 33/574 (2006.01) G01N 33/68 (2006.01)

Patent

CA 2000308

ABSTRACT The present invention is directed to the measurement of soluble T cell growth factor receptors, soluble T cell differentiation antigens, or related soluble molecules or fragments thereof, and the use of such measurements in the diagnosis and therapy of diseases and disorders. Specific embodiments involve the diagnosis and monitoring of therapy using absolute values of such soluble molecules. Further embodiments involve detecting a change in the levels of such soluble molecules, in the diagnosis and therapy of diseases and disorders. In specific embodiments, detection of increases in both soluble IL2R and creatinine in the body fluid of a transplant patient can be used to differentially diagnose renal allograft rejection from infection. The invention is also directed to methods for measurement of soluble CD4 antigens, which measurements can be used, in a specific embodiment, to diagnose a state of immune activation, to diagnose rheumatoid arthritis, or to stage adult T cell leukemia in a patient. In another embodiment, soluble CD4 levels can be used to monitor the efficacy of disease treatments, a specific embodiment including monitoring therapy of HIV-infected patients. In another aspect, the invention relates to the detection, staging, or monitoring of therapy of diseases and disorders by measuring a plurality of soluble T cell markers.

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